The importance of research in the context of quality improvement cannot be stressed too much. Research provides new knowledge that should be used to guide future practice. It is important that centres become involved in research, as this will provide knowledge of the local situation. It may not be appropriate to implement changes based on data from centres in other global regions, due to possible marked differences in populations, disease profiles, co-morbidities, and treatments.
Retrospective studies are a very useful method that helps to determine the outcomes achieved by a service. Retrospective studies in oncology frequently relate to the outcome of a particular disease, with the typical endpoints being survival, disease free survival, local control and the rate of specified complications. Through statistical analysis that corrects for differences in the major variables, comparison of the outcomes with published data provides a guide to the performance of the centre. In this manner retrospective studies may serve to generate hypotheses that should be tested in prospective studies.
Prospective clinical studies are utilised to gather new data or to test hypotheses. In most cases in oncology, prospective clinical studies can be classified into 3 broad categories, being phase I, phase II and phase III studies. These are defined briefly as:
- Phase I study - This is used predominantly in new drug assessment, and involves assessment of the pharmacology and tolerability of drugs
- Phase II study - This utilises the results of the phase I study to determine whether the drug or other treatment demonstrates efficacy in the treatment of a particular cancer and whether this new treatment shows sufficient promise to warrant a phase III trial.
- Phase III study - The phase III study is a randomised controlled clinical trial, in which the new treatment is compared with the current standard treatment.
ARBR is actively involved in a number of Phase II studies. For example, a large work program is related to resource sparing studies, in which a novel hypofractionated radiation schedule is compared with a standard schedule.